E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Plain-language guide to NCT02918630: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 7 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02918630
Phase: not phased
Status: completed
Start: 2016-10
Completion (planned or actual): 2017-08
Participants: 7 (actual)
Design: randomized, open label (everyone knows who gets what), prevention
Conditions studied: Tobacco Smoking
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Nicotine Replacement Therapy - Nicotine Patch (active comparator) and Nicotine Replacement Therapy + E-cigarette (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 7 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be diagnosed with schizophrenia. Be in stable medical condition (DSM-V). Report smoking ≥10 tobacco cigarettes/day. Present a breath CO ≥10 ppm. Be fluent in English.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: be currently pregnant or breastfeeding; report wanting to quit smoking in the immediate future; test positive for illicit drugs except thc.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Being open-label, the Therapeutic nicotine (patch, non-peptide) study did not mask who received what.

It started in 2016-10 with completion listed for 2017-08.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in Smoking as Assessed by Breath Carbon Monoxide Levels (time frame: Baseline, Week 5). Change in Smoking as Assessed by Urinary Cotinine Levels (time frame: Baseline, Week 5). Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back (time frame: Baseline).

It also tracked 1 secondary outcome, for example Feasibility as Assessed by Percent of Participants Who Completed the Study.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 7 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.